Validation and Qualification in Analytical Laboratories
by
Ludwig Huber
Book Details
Format
Hardback or Cased Book
ISBN-10
084938267X
ISBN-13
9780849382673
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Jul 23rd, 2007
Print length
314 Pages
Weight
584 grams
Dimensions
23.80 x 15.90 x 2.20 cms
Product Classification:
PharmacologyPharmaceutical technology
Ksh 34,200.00
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Validation and Qualification in Analytical Laboratories
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
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